510(k) K100812 ยท FMI Needle, Hypodermic, Single Lumen
ULTICARE DISPOSABLE PEN NEEDLES
| Applicant | Ultimed, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 3, 2010 |
| Received | Mar 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100812
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.